CLASS II ONGOING Device recall · Reported 3 Jan 2024 · FDA Enforcement Report

Arjo medical beds recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o

Arjohuntleigh Polska Sp. z.o.o is recalling Arjo medical beds, distributed in 7 states. The recall was initiated on 29 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 0505609734548, serial numbers: P0504690, P0504691, P0510813, P0512547, P0512548, P0515453, P0515454, P0515455, P0515456, P0515457, P0516242, P0517649, P0517650, P0517651, P0517652, P0517653, P0517654, P0517655, P0517656, P0517657, P0517658, P0519068, P0525670, P0525671, P0525672, P0525673, P0525674, P0525675, P0525676, P0525677, P0525678, P0525679, P0525680, P0525681, P0525682, P0525683, P0525684, P0525685, P0525686, P0526405, P0526406, P0526407, P0526408, P0526409, P0526410, P0526425, P0526426, P0526427, P0526428, P0526429, P0526430, P0526431, P0526432, P0527297, P0527298, P0527299, P0527300, P0527301, P0527302, P0529533, P0529534, P0529535, P0529536, P0494034, P0494035, P0494036, P0494037, P0494038, P0494039, P0494040, P0494041, P0494042, P0494043, P0494044, P0494045, P0494046, P0494047, P0494048, P0501255, P0501256, P0501257, P0501258, P0501259

Quantity recalled83 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0611-2024
FDA event ID: 93463
Recalling firm: Arjohuntleigh Polska Sp. z.o.o, Komorniki
Classification: Class II
Status: Ongoing
Recall initiated: 29 Aug 2023
FDA classified: 22 Dec 2023
Reported: 3 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

29 Aug 2023	Recall initiated by company
22 Dec 2023	Classified by FDA	+115 days
3 Jan 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Unintended movement of bed wheels

Product as listed by the FDA

Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules

Where it was distributed

US: TN, CA, NY, IL, NV, PA, SD

California Illinois Nevada New York Pennsylvania South Dakota Tennessee

Questions about this recall

Why was it recalled?

Unintended movement of bed wheels

Which lots are affected?

UDI/DI 0505609734548, serial numbers: P0504690, P0504691, P0510813, P0512547, P0512548, P0515453, P0515454, P0515455, P0515456, P0515457, P0516242, P0517649, P0517650, P0517651, P0517652, P0517653, P0517654, P0517655, P0517656, P0517657, P0517658, P0519068, P0525670, P0525671, P0525672, P0525673, P0525674, P0525675, P0525676, P0525677, P0525678, P0525679, P0525680, P0525681, P0525682, P0525683, P0525684, P0525685, P0525686, P0526405, P0526406, P0526407, P0526408, P0526409, P0526410, P0526425, P0526426, P0526427, P0526428, P0526429, P0526430, P0526431, P0526432, P0527297, P0527298, P0527299, P0527300, P0527301, P0527302, P0529533, P0529534, P0529535, P0529536, P0494034, P0494035, P0494036, P0494037, P0494038, P0494039, P0494040, P0494041, P0494042, P0494043, P0494044, P0494045, P0494046, P0494047, P0494048, P0501255, P0501256, P0501257, P0501258, P0501259

Where was it sold?

US: TN, CA, NY, IL, NV, PA, SD

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 93463

Reported	Class	Recall	Company	Reason	Where
3 Jan 2024	CLASS II	Arjo medical beds recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o	Arjohuntleigh Polska Sp. z.o.o	Other	7 states

More recalls from Arjohuntleigh Polska Sp. z.o.o

All 10

Reported	Class	Recall	Company	Reason	Where
22 Apr 2026Device	CLASS II	Arjo Tenor mobile passive patient lift recalled	Arjohuntleigh Polska Sp. z.o.o	Device Malfunction	Nationwide
3 Jan 2024Device	CLASS II	Arjo medical beds recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o	Arjohuntleigh Polska Sp. z.o.o	Other	7 states
1 Jun 2022Device	CLASS I	Sara Plus Active Floor Lift recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o	Arjohuntleigh Polska Sp. z.o.o	Other	Nationwide
6 Oct 2021Device	CLASS II	Arjo Citadel beds originally assembled recalled	Arjohuntleigh Polska Sp. z.o.o	Other	Nationwide
26 Aug 2020Device	CLASS II	Bariatric Bed Frame System The Citadel Plus Bariatric Bed recalled	Arjohuntleigh Polska Sp. z.o.o	Other	Nationwide

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